MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SERIES 7000 STANDARD TIBIA; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	7115-0007
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that the tibial base plate was marked when they took it out of the pack.The surgeon chose not to use the device and completed the case with an alternative.
Additional Manufacturer Narrative
An event regarding appearance involving a scorpio baseplate was reported.The event was confirmed.A visual inspection indicated the device was returned in new condition.There are some marks on the surface of the baseplate.The markings found on the baseplate are cosmetic.A dimensional was conducted and met specifications.Clinician review: not performed as medical records were not received for review with a clinical consultant.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for this lot.Conclusions: the reported event regarding appearance (marks on the device) was confirmed.A visual inspection noted there are some marks on the surface of the baseplate.The markings found on the baseplate are cosmetic.However, the root cause could not be determined.Review of the device by a operation supplier quality specialist indicated the visible marks on the baseplate meet their specifications and would pass inspection.No further investigation for this event is needed.If additional information is received, this investigation will be reopened and re-evaluated.
Event or Problem Description
The customer reported that the tibial base plate was marked when they took it out of the pack.The surgeon chose not to use the device and completed the case with an alternative.

• Brand Name: SERIES 7000 STANDARD TIBIA
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7139928
• Report Number: 0002249697-2017-03663
• Device Sequence Number: 1091452
• Product Code: JWH
• UDI-Device Identifier: 07613327033366
• UDI-Public: 07613327033366
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K910990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2022
• Device Catalogue Number: 7115-0007
• Device Lot Number: 3077MXA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 02/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other